Dealing with mounting pressure to speed up the distribution of COVID vaccines in the country, The central government has agreed to expedite emergency clearance for Covid vaccines, which are widely used in Western countries and Japan. This will directly enable vaccine manufacturers from outside India, such as Johnson and Johnson (Bio E), Zydus Cadila, Serum’s Novavax and a nasal vaccine from Bharat Biotech., to market vaccines that have not been subjected to India-specific studies but have shown strong safety profiles in other global regulators trials.
The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), Japan’s Pharmaceuticals and Medical Devices Agency, and the World Health Organization (WHO) have all granted emergency use permission to Pfizer and Moderna vaccines.
Following extensive deliberation, the NEGVAC suggested that vaccines for COVID, which have been produced and developed in other countries and have been given emergency approval for limited use by global regulators, be used. “We hope and invite vaccine manufacturers like Pfizer, Moderna, Johnson & Johnson, and others…to be able to come to India as soon as possible,” VK Paul, chairman of the National Expert Committee on Vaccine Administration, said.
Sputnik V, a Russian-made vaccine, has already received emergency approval in India. It is believed that these vaccines will be available by Q3. Though J&J is working towards reaching the Indian market as soon as possible. But Pfizer withdrew from the race in February due to regulatory issues. Novavax, on one hand, started testing in India in March with the aim of launching it in September. Moderna, on the other hand, is still in early talks with the CSIR about a potential collaboration. It will take a few more months to roll out the vaccine in the Indian market.